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Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2018-19

Published By :

BioInformant

Published Date : Oct 2018

Category :

Stem Cell

No. of Pages : 145 Pages

Groundbreaking experimentation in 2006 led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells which are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression, as well as other methods. Research and experimentation using mouse cells by Shinya Yamanaka’s lab at Kyoto University in Japan was the first instance in which there was a successful generation of iPSCs.

In 2007, a series of follow-up experiments were done at Kyoto University in which human adult cells were transformed into iPSCs. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.

Since the discovery of iPSCs a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. While it is clear that iPSCs represent a lucrative product market, methods for commercializing this cell type are still being explored, as clinical studies investigating iPSCs continue to increase in number.

iPS Cell Therapies

2013 was a landmark year in Japan because it saw the first cellular therapy involving transplant of iPS cells into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB). Dr Takahashi was investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration.

Although the study was suspended in 2015 due to safety concerns, in June 2016 RIKEN Institute announced that it would resume the clinical study using allogeneic rather than autologous iPSC-derived cells, because of the cost and time efficiencies.
In a world-first, Cynata Therapeutics (ASX: CYP) received approval in September 2016 to launch the world’s first formal clinical trial of an allogeneic iPSC-derived cell product, called “CYP-001.” The study involves centres in the UK and Australia. In this trial, Cynata is testing an iPS cell-derived mesenchymal stem cell (MSC) product for the treatment of GvHD.

On 16 May 2018, Nature News then reported that “Japan’s health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts.” The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to “create a sheet of 100 million heart-muscle cells.” From preclinical studies in pigs, the medical team determined that thin sheets of cell grafts can improve heart function, likely through paracrine signalling.

Kyoto University Hospital in Kobe, Japan also stated it would be opening an iPSC therapy center in 2019, for purposes of conducting clinical studies on iPS cell therapies. Officials for Kyoto Hospital said it will open a 30-bed ward to test the efficacy and safety of the therapies on volunteer patients, with the hospital aiming to initiate construction at the site in February of 2016 and complete construction by September 2019.

iPS Cell Market Competitors

  • In 2009 ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, was the first to make iPSC products commercially available with the launch of its human iPSC-derived cardiomyocytes, which it called “ReproCario.
  • Cellular Dynamics International, a Fujifilm company, is another major market player in the iPSC sector. Similar to ReproCELL, CDI established its control of the iPSC industry after being founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who in 2007 derived iPSC lines from human somatic cells for the first time ever (the feat was accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan).
  • A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics. Founded in 2001 and headquartered in Cologne, Germany, Axiogenesis initially focused on generating mouse embryonic stem cell derived cells and assays. After Yamanaka’s groundbreaking iPSC technology became available, Axiogenesis was the first European company to license and adopt Yamanaka’s iPSC technology in 2010.
  • Ncardia’s focus lies on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells, although it is expanding into new areas. Its flagship offering is its Cor.4U human cardiomyocyte product family, including cardiac fibroblasts.

In summary, market leaders have emerged in all areas of iPSC development, including:

  • Drug Development and Discovery: CDI, a Fujifilm Company, in Madison, Wisconsin; Ncardia in Cologne, Germany
  • Cellular Therapy: RIKEN Center, in Kobe, Japan; Kyoto University in Kyoto, Japan; Cynata Therapeutics in Australia
  • Stem Cell Biobanking: CDI, a Fujifilm Company, in Madison, Wisconsin; ORIG3N in Boston, Massachusetts
  • iPSC Research Products: CDI, a Fujifilm Company; Ncardia, ReproCELL; Thermo Fisher Scientific; STEMCELL Technologies; BD Biosciences; Axol Bioscience; and many more
  • iPS Cell Commercialization

There are four major areas of commercialization for induced pluripotent stem cells, as described below:

  • Drug Development & Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.
  • Cellular Therapy: iPSCs are being explored in cellular therapy applications for purposes of reversing injury or disease.
  • Toxicology Screening: iPSCs can be used for toxicology screening, which is the use of stem cells or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.
  • Stem Cell Biobanking: iPSC repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC-derived cell types produced from both healthy and diseased donors.

iPS Cell Report Key Findings

  • Key report findings included in this global strategic report include:
  • Market Size Determination for the iPSC Market
  • Market Segmentation by Product Category, Application, and Geography
  • 5 Year Market Projections through 2022
  • Trend Analysis of iPSC Grants
  • Trend Analysis of iPSC Clinical Trials
  • Trend Analysis of iPSC Scientific Publication
  • Analysis of iPSC Patent and IP Environment
  • SWOT Analysis for the iPSC Market
  • Competitive Analysis of iPSC Market Leaders
  • Profiles of iPSC Market Leaders

Table of Content

SCOPE AND METHODOLOGY
Market Definition
Market Scope
Market Stakeholders
Research Methodology
Secondary and primary research methodology
Market Size Estimation Methodology
Market Forecast Methodology
Assumptions
Years Considered for the Study
Currency
EXECUTIVE SUMMARY
Introduction
BACKGROUND – iPSC RESEARCH
About iPSCs
Importance of iPSCs in Modern Medical Science
Evolution of iPSC Research and Application
Table Timeline of iPSC Events
Scientific Discoveries and Progress Since Discovery of iPSCs
Brain Cortex from iPSCs
Organoids
CRISPR-Cas9.
Neurodegenerative Disorder Treatment
Adult Human Cardiomyocytes
Potential Future Use of iPSCs
Hepatic Differentiation of Human iPSCs
Disease Modelling with Human iPSCs
Drug Toxicity and Drug Discovery using Human iPSCs
Therapeutic Potential of Human iPSCs
3D Culture Technique
Present Day Utilizations
Drug Development and Discoveries
Cellular Therapy
Toxicology Screening
Stem Cell Biobanking (Also called iPSC Banks)
Cancer Research
iPS Cells in Dentistry
Recent Research & Clinical Updates
Building the World's largest iPSC Repository
First Investigator Led Clinical Study with iPSCs (Macular Degeneration)
Japanese Individual is First to Receive 'Reprogrammed' Stem Cells from Another Person
Cynata Therapeutics Launches World's First Clinical Trial with an Allogeneic iPSC-Derived Therapeutic Product
Physician-lead Study Using iPSCs for Parkinson's Disease at Kyoto University
Directed differentiation of human iPSC into insulin producing cells
iPSC-derived CAR-T Cell Cancer Immunotherapies
Induced Pluripotent Stem Cells (iPSCs) for Other Retinal Diseases
Differentiation of human and murine induced pluripotent stem cells to microglia-like cells
Advantages and Disadvantages of iPSC
The Advantages of iPS Cells27
The Disadvantages of iPS Cells29
Recent Activity by iPSC Research Supply Companies
Ncardia and Nanion Technologies
FUJFILM Cellular Dynamics and University of California - Irvine
Evotec and Celgene
Kyoto University (ESCs)
Ncardia (Merger of Pluriomics and Axiogenesis)
ID Pharma and Axol Bioscience
Evotec and Censo Biotechnologies
ORIG3N
Fujifilm Establishes CDI Japan
Stemgent Company
Fujifilm Holdings
ReproCELL
Recent Activity by iPSC Cell Therapy Companies & Organizations
Fate Therapeutics and ONO Pharmaceutical
Cynata Therapeutics (Positive Phase I Data)
Center for iPS Cell Research & Application (CiRA), Kyoto University
Osaka University
Fujifilm and Takeda Pharmaceutical
BlueRock Therapeutics and Universal Cells
RIKEN
Fujifilm Takes Equity Stake in Cynata Therapeutics
Cellular Dynamics International (CDI)
RIKEN Centre for Developmental Biology (CDB)
MARKET ANALYSIS BY PRODUCT CATEGORY
Market Segments
Key Findings
Introduction
Table Global iPSC Market, by Product Category, USD Million, 2015 – 2022
Reprogramming
Table Global iPSC Reprogramming Market, by Geography, USD Million, 2015 – 2022
Cell Culture
Table Global iPSC Cell Culture Market, by Geography, USD Million, 2015 - 2022
Differentiation
Table Global iPSC Differentiation Market, by Geography, USD Million, 2015 - 2022
Cell Analysis
Table Global iPSC Cell Analysis Market, by Geography, USD Million, 2015 - 2022
Engineering
Table Global iPSC Engineering Market, by Geography, USD Million, 2015 - 2022
Others
Table Global iPSC Other Product Category Market, by Geography, USD Million, 2015 - 2022
MARKET ANALYSIS BY APPLICATION
Key Findings
Introduction
Table Global iPSC Market, by Application, USD Million, 2015 - 2022
Academic Research
Table Global iPSC Market for Academic Research Application, by Geography, USD Million, 2015 - 2022
Drug Development & Discovery
Table Global iPSC Market for Drug Development & Discovery Application, by Geography, USD Million, 2015 - 2022
Cellular Therapy
Table Global iPSC Market for Cellular Therapy Application, by Geography, USD Million, 2015 - 2022
Toxicology Screening
Table Global iPSC Market for Toxicology Screening Application, by Geography, USD Million, 2015 - 2022
Stem Cell Biobanking
Table Global iPSC Market for Stem Cell Biobanking, by Geography, USD Million, 2015 - 2022
MARKET ANALYSIS BY GEOGRAPHY
Key Findings
INTRODUCTION
Table Global iPSC Market, by Geography, USD Million, 2015 – 2022
NORTH AMERICA
Table North America iPSC Market for Academic Research Application, by Country, USD Million, 2015 - 2022
Table North America iPSC Market, by Product Category, USD Million, 2015 - 2022
Table North America iPSC Market, by Application, USD Million, 2015 - 2022
Table U.S. iPSC Market, by Product Category, USD Million, 2015 - 2022
Table U.S. iPSC Market, by Application, USD Million, 2015 - 2022
EUROPE
Table Europe iPSC Market, by Product Category, USD Million, 2015 – 2022
Table Europe iPSC Market, by Application, USD Million, 2015 - 2022
APAC
Table APAC iPSC Market for Academic Research Application, by Country, USD Million, 2015 – 2022
Table APAC iPSC Market, by Product Category, USD Million, 2015 - 2022
Table APAC iPSC Market, by Application, USD Million, 2015 - 2022
Table Japan iPSC Market, by Product Category, USD Million, 2015 – 2022
Table Japan iPSC Market, by Application, USD Million, 2015 - 2022
Rest of the World (ROW)
Table RoW iPSC Market, by Product Category, USD Million, 2015 - 2022
Table RoW iPSC Market, by Application, USD Million, 2015 - 2022
SCIENTIFIC PUBLICATIONS
Key Findings
OVERVIEW OF iPSC RESEARCH ACTIVITY
Table iPSC Scientific Publications by Year (2006 to 2017) 68
PATENTS
Key Findings
INTRODUCTION
PATENT LIST
PATENT BY GEOGRAPHY
Commentary
PATENT BY CATEGORY
Commentary
COMPANIES
iPSC Competitive Landscape
Table List of companies offering iPSC Products
Table List of companies developing iPSC-derived cellular therapeutics
FEATURED COMPANY PROFILES
Featured Companies Specializing in iPSC Products
Cellular Dynamics International (CDI), a Fujifilm Company
Ncardia
ReproCELL
Axol Bioscience
Featured Companies that are Broad Providers of Research Tools, Including iPSC Products
Lonza
Thermo Fisher Scientific
Takara Bio
Featured Companies Developing iPSC-Derived Cell Therapeutics
Cynata Therapeutics
Fate Therapeutics
Megakaryon Corporation
RIKEN
ORIG3N
CONCLUSIONS

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